Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
AUDIENCE: Pharmacy, Oncology, Nursing
ISSUE: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
See the Health Care Provider Letter for important prescribing information to reflect the new safety information..
BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.
RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.
Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.
If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,
• administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
• appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
• Varubi (rolapitant) injectable emulsion should be permanently discontinued.
Read the MedWatch Safety Alert, including a link to the Health Care Provider Letter, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592592.htm
Varubi (rolapitant) injectable emulsion核可用於預防延遲型化學治療造成的噁心嘔吐，Varubi與其他止吐藥品併用，亦可預防成人高致吐性化學治療所造成的噁心嘔吐。Varubi上市後曾被報導出現全身性過敏反應(anaphylaxis)、過敏性休克(anaphylactic shock)及其他嚴重過敏反應(hypersensitivity reactions)，有一些嚴重不良反應尚需住院。這些反應可能發生於輸注Varubi期間或輸注完畢後，大部份的不良反應皆於給藥後的前幾分鐘發生。過敏的症狀包含哮喘音、呼吸困難；臉部或喉嚨腫脹；蕁麻疹或發紅；癢；腹部絞痛、腹痛或嘔吐;背痛或胸痛;低血壓或休克。
醫療專業人員必須小心所有接受Varubi的病人其給藥期間和給藥後是否出現過敏症狀。建議醫療專業人員與病人確認是否對該產品的任何成分，包括大豆油（soybean oil）過敏，此外已知對豆類或其他相關過敏原過敏的病人，由於可能有交叉反應(cross reaction)，亦需於給藥時密切監測。可能會產生過敏反應的病人不應使用Varubi。若於使用Varubi治療期間出現過敏反應，應立即給予適當的治療：
1. 需立即停用Varubi
2. 給予適當的藥物治療（包含epinephrine antihistamines）
3. Varubi應永久停用
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592592.htm
[Posted 1/16/2018]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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